FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE ORIGINAL LEINBACH PLATFORM TOTAL HIP
K Number: K820755
·
Decision Jun 10, 1982
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
16
Review Days
83
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Basic Information
- Device Name
- THE ORIGINAL LEINBACH PLATFORM TOTAL HIP
- K Number
- K820755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Allo Pro Corp.
- Date Received
- March 19, 1982
- Decision Date
- June 10, 1982
- Product Code
- KWL
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | FDA class 2 | Orthopedic |
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Other Clearances by Allo Pro Corp.
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|---|---|---|---|
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| K896669 | WEBER PERMALOCK | Feb 6, 1990 | Substantially Equivalent for Some Indications |
| K892644 | BIOLOX CERAMIC BALL | Oct 19, 1989 | Substantially Equivalent |
| K885049 | RS-CUP ACETABULAR PROSTHESIS | Jan 13, 1989 | Substantially Equivalent |
| K864999 | KENNEDY STEM | Sep 9, 1987 | Substantially Equivalent |
| K871453 | ZWEYMUELLER-SL HIP PROSTHESIS STEM | Jul 13, 1987 | Substantially Equivalent |
| K851213 | ZWEYMULLER CUP | May 28, 1985 | Substantially Equivalent |
| K841391 | WEBER-STUHMER HIP PROSTHESIS STEM | Apr 13, 1984 | Substantially Equivalent |